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 25 May 2018

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Randomised study of tacrolimus vs ciclosporin in young liver transplant patients

A randomized, open-label trial of tacrolimus for prevention of liver transplant rejection in children, published in The Lancet, finds it is safe and effective.

News image

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Previous studies have shown that tacrolimus is more efficacious than ciclosporin microemulsion in the prevention of acute rejection in adult recipients of liver allografts.

Professor Kelly and colleagues undertook a study to compare these drugs in children undergoing liver transplantation.

In a 12-month multicentre, open-label, parallel-group, randomised study, the researchers compared a dual tacrolimus regimen (tacrolimus/corticosteroids, n=93) with a triple ciclosporin microemulsion regimen (ciclosporin microemulsion/corticosteroids/azathioprine, n=92).

All the participants were children who had had liver transplants (age 16 years, bodyweight 40 kg).

Doctors administered initial oral daily doses of 0•30 mg/kg for tacrolimus and 10 mg/kg for ciclosporin microemulsion.

The primary endpoint the research group considered was the incidence of and time to first histologically proven acute rejection.

The team excluded patients from analysis if they did not receive the study drug, or were given incorrect medication.

The remaining patients were analyzed in accordance with their random treatment allocation, irrespective of whether they switched medication during the trial.

Acute rejection-free rate was 55•5% for patients on tacrolimus and 40•2% for patients on ciclosporin microemulsion
The Lancet

The median age of the participants was 22 months in the tacrolimus group and 17 months in the ciclosporin microemulsion group.

The researchers did not note any difference between treatment groups with respect to patient survival or graft survival at month 12 after transplant.

The group found at the end of the study that the acute rejection-free rate at study end (Kaplan-Meier method) was 55•5% for patients on tacrolimus and 40•2% for patients on ciclosporin microemulsion.

In addition, the Kaplan-Meier estimate of patients free from corticosteroid-resistant acute rejection at study end was 94•0% for tacrolimus-treated patients and 70•4% for ciclosporin-microemulsion-treated patients.

Professor Kelly commented, "Overall, incidence of adverse events did not differ between groups."

"Tacrolimus is a safe and effective treatment for the prevention of rejection after liver transplantation in children".

The Lancet; 2004; 364: 1054-61
07 October 2004

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